Incorporating clinical outcomes and economic consequences into drug formulary decisions: a practical approach.

BACKGROUND: In 1994, Regence BlueShield (Regence), a large non-staff model health plan, adopted guidelines governing the review of new and existing drug products. However, certain limitations were apparent: adequate data were not available in a timely fashion; unpublished studies and information on unapproved indications were difficult to obtain; data addressing humanistic and economic outcomes were not routinely supplied by manufacturers; and the time required by Regence staff clinical pharmacists to assemble and summarize published clinical studies for the pharmacy and therapeutics (P&T) committee was excessive. OBJECTIVE: To describe the process used by Regence to collect and review clinical, economic, and other health outcomes data as part of the plan's drug formulary adoption process. PROCESS DESCRIPTION: To address these limitations, Regence revised its process to require pharmaceutical manufacturers to submit a detailed dossier with clinical and economic data from published and unpublished studies, along with a disease-based economic model projecting the potential impact that introducing the product would have on health outcomes and economic consequences occurring across the entire Regence system. After performing independent literature reviews to ensure the accuracy and comprehensiveness of the information obtained, clinical pharmacists at Regence complete a detailed summary of each drug for the P&T committee. CONCLUSION: The new process has addressed the limitations of the previous system and, by improving the timeliness and relevance of available information, it supports Regence's goal of maintaining an evidence-based formulary.

Diagnosis related groups and the critically injured.

We reviewed the records of 59 patients with trauma treated in the surgical intensive care unit in 1983 to attempt to identify a diagnosis related group (DRG) modifier in order to eliminate major losses which would be incurred in caring for the critically injured. There were 22 females and 37 males. Payment based upon a DRG system would have resulted in hospital losses for the following subgroups: surgical treatment (n = 44) $1,348,009; no operation (n = 15) $125,085; length of stay (LOS) of more than ten days (n = 35) $1,124,778; LOS equal to or less than ten days (n = 24) $348,316; nonsurvivors plus LOS equal to or less than ten days plus operation (n = 12) $269,778, and survivor plus LOS greater than ten days plus operation (n = 29) $1,022,284. No useful modifier was identified for these subgroups using regression analysis. We believe that some immediate DRG modifier, based upon the total hospital charges (or costs if known) relationship to total DRG payments, should be created until further refinements in payment systems evolve. If some correction is not attempted, the considerable disadvantage which would result to participating hospitals may result in curtailing availability of effective long term intensive care unit trauma care at a time when the public is becoming aware of trauma systems and the improvement in survival seems to be a realizable goal.

Diagnosis-related groups and the salvagable trauma patient in the intensive care unit.

We reviewed 59 patients with trauma treated in the surgical intensive care unit (SICU) in 1983 comparing hospital charges with payments calculated from diagnosis-related groups (DRG). There were 37 male and 22 female patients with a mean age of 38.3 years. The mechanism of injury was blunt trauma in 42 and penetrating injury in 17 patients. The mean injury severity score (ISS) was 30.7 +/- 13.8 (mean plus or minus standard deviation). The duration of SICU care was 5.4 +/- 6.1 days. Over-all, 18 patients died. For the entire group, payment based upon a DRG system would have resulted in an over-all loss of $1,468,094.00 or $24,883.00 dollars per patient. Calculated DRG payments would have accounted for only 32.3 per cent of the total hospital charges. Calculated losses for 41 survivors would have been $1,098,431.00 dollars. Length of stay had a significant relationship to the calculated DRG payment (r = 0.69, p less than 0.001) but account for only 48 per cent of the variance. DRG only accounted for 26 per cent of the variance in charges despite a statistically significant relationship (r = 0.51, p less than 0.001). No statistically significant relationship was found between ISS and hospital charge by linear regression (r = 0.20, p greater than 0.01) or between ISS and DRG payment (r = 0.14, p less than 0.4). DRG as presently formulated would only pay one-third of total hospital charges for patients with trauma requiring SICU care. Present DRG payment schedules reflect neither the elements of care currently expended nor the modifiers necessary to adjust for acuity and severity. The ISS score would not be a useful modifier to correct DRG payment in this high cost group.

Preventable trauma deaths: Dade County, Florida.

We reviewed 1,201 trauma deaths that occurred in Dade County, Florida, in 1982 in order to evaluate the need for an organized trauma network. There were 715 deaths (59.5%) at the scene. Of the remaining 486 patients who were transported to hospitals for treatment there were 240 central nervous system (CNS) deaths and 246 non-CNS deaths. Fifty-two (21.1%) preventable non-CNS trauma deaths were identified out of the 246 non-CNS deaths. The lack of an appropriate surgical procedure or a delay to surgery accounted for 82.7% of the preventable deaths. The preventable non-CNS death rate was 12.1% at the then functional Level I hospital and 26.4% at the other 22 hospitals (p less than 0.01). The ISS scores were similar for both the functional Level I hospital and the other hospitals. A trauma network involving seven hospitals is currently being established in Dade County, Florida. Applying the 1982 data to these hospitals reveals a preventable non-CNS death rate of 12.1% for the Level I hospital, 21.5% for the six planned Level II hospitals, and 30.0% for the other 16 hospitals. We conclude that: the severely injured should be triaged directly to trauma centers, and there is a need in Dade County, Florida, for an organized trauma system.

A prospective randomized study of moxalactam versus gentamicin and clindamycin in penetrating abdominal trauma.

We conducted a randomized, prospective study of moxalactam versus gentamicin plus clindamycin in 42 patients with penetrating abdominal trauma. Patients were randomized to receive intravenously either 2 grams of moxalactam every 12 hours or 80 milligrams of gentamicin every eight hours and 600 milligrams of clindamycin every six hours. Antibiotics were administered preoperatively and continued for a minimum of five days if hollow viscus injury occurred. For those without hollow viscus injury, only those patients receiving a minimum of three days of antibiotics were evaluated. A single intramuscular dose of 10 milligrams of vitamin K was also administered to all patients in the moxalactam group. There were 39 males and three females with a mean age of 33 years. Twenty patients received moxalactam and 22 received gentamicin plus clindamycin. The mechanism of injury was gunshot wound in 32 patients and stab wounds in ten patients. Eight patients in each group sustained injuries to the small intestine or colon, or both. The mean injury severity score was 22.6 and 21.2 in the single and double antibiotic regimen, respectively. The mean duration of antibiotic therapy was 5.8 and 7.0 days in the single and double antibiotic group, respectively. No infectious complications occurred in the moxalactam group whereas five infections occurred in four patients in the gentamicin plus clindamycin group (p less than 0.05). These infections included one intra-abdominal abscess, two wound infections and two episodes of necrotizing fasciitis of the wound and abdominal wall. There were no complications attributable to moxalactam therapy. The over-all mortality rate was zero per cent. The total pharmacy cost of a five day course of moxalactam plus a single dose of vitamin K is $204.67 compared with $226.00 for a similar course of gentamicin plus clindamycin. We conclude that: moxalactam is at least, if not more, effective in preventing infectious complications after penetrating abdominal trauma compared with gentamicin plus clindamycin; moxalactam is safe in the doses used when combined with vitamin K, and 3, moxalactam is more cost-effective than gentamicin plus clindamycin dual antibiotic therapy.

Noise raises blood pressure without impairing auditory sensitivity.

Two rhesus monkeys, exposed continuously to realistic patterns and levels of noise for 9 months, exhibited sustained elevations in blood pressure that did not return to baseline values after the noise ended. Auditory brainstem responses, measured before and after exposure, indicated no change in auditory sensitivity.